NCT06690541

Real-world Study of Local Therapy Changes During 1L Lorlatinib in Unresectable ALK+ NSCLC

A Real-world Study to Explore Therapeutic Changing Mode of Locally Therapy During 1L Lorlatinib Treatment in Unresectable ALK+ NSCLC Patients

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This real-word study is designed to prospectively explore whether local treatment (surgery, ablation, radiotherapy and others) can prolong the time to treatment discontinuation during 1L lorlatinib treatment in Chinese patients with unresectable ALK+ NSCLC. Participation in this study is not intended to change the routine treatment received as determined by their attending physicians. Patients will be treated according to the routine medical practice in terms of visit frequency and types of assessments performed.

Conditions

• Lung Cancer, Non-Small Cell

Interventions

Type	Name	Description
DRUG	Lorlatinib 100 mg	Patients received continuous daily PO dosing of lorlatinib 100mg QD from the date of first dosing (per the current protocol) or until one of the following criteria were met (whichever occurred first): disease progression; initiation of a new anticancer therapy; unacceptable toxicities; global deterioration of health-related symptoms; pregnancy; withdrawal of consent; loss to follow-up; death; investigator decision dictated by protocol non-compliance; or study termination.

Timeline

• Start date: 2024-11-10
• Primary completion: 2027-04-30
• Completion: 2030-10-31
• First posted: 2024-11-15
• Last updated: 2024-11-15